What is the mechanism of action of this treatment?

The most common treatments for Nonepileptic Seizures (PNES) that align with the principles of Retraining and Control Therapy (ReACT) involve cognitive-behavioral therapy (CBT) and other psychotherapeutic approaches. These treatments work by helping patients identify and modify dysfunctional thoughts and behaviors that contribute to their seizures. By improving the patient's sense of control and reducing catastrophic symptom expectations, these therapies can decrease the frequency and severity of PNES episodes. This is crucial for PNES patients as it addresses the underlying psychological factors, leading to better management of their condition and an improved quality of life.

What side effects are associated with this type of intervention?

Behavioral and cognitive therapies, such as Retraining and Control Therapy (ReACT), are commonly used to treat psychogenic non-epileptic seizures (PNES). These therapies aim to change behaviors and thought patterns associated with the seizures. Known side effects are generally minimal but can include temporary increases in anxiety or emotional distress as patients confront and work through their issues. Additionally, some patients may experience frustration or fatigue from the therapeutic process. Overall, these treatments are considered safe and are well-tolerated by most patients.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Nonepileptic Seizures (PNES). The management of PNES typically involves non-pharmacological approaches such as cognitive-behavioral therapy (CBT) and other psychotherapeutic interventions aimed at addressing the underlying psychological factors. The Retraining and Control Therapy (ReACT) trial, which focuses on changing behaviors and thoughts, aligns with these established treatment methods. Therefore, the primary treatments for PNES are behavioral and cognitive therapies rather than pharmacological interventions.

What other types of research exist?

Promising novel alternatives to Retraining and Control Therapy (ReACT) for Nonepileptic Seizures (PNES) patients include: 1) Virtual Reality Exposure Therapy (VRET), which has shown effectiveness in treating PTSD and anxiety disorders by immersing patients in controlled virtual environments to process traumatic experiences. 2) Transcranial Magnetic Stimulation (TMS), a non-invasive neuromodulation technique that has been effective in treating depression and may help in modulating neural circuits involved in PNES. 3) Cognitive Behavioral Therapy (CBT) with a focus on trauma and stress management, which has been adapted for various psychological conditions and could be tailored for PNES patients.

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Behavioral Intervention

Cognitive Behavioral Therapy for Nonepileptic Seizures

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

9-18 years old

Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG

Must not have

Comorbid Epilepsy

Severe intellectual disability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 months

Awards & highlights

Summary

This trial tests ReACT therapy for children aged 11-18 with PNES. The therapy aims to help them feel more in control and less worried about their symptoms, potentially reducing seizure-like episodes.

Who is the study for?

This trial is for young people aged 9-18 with a diagnosis of psychogenic non-epileptic seizures (PNES) confirmed by video-EEG. They must experience at least four PNES per month and have a family member willing to participate. It's not suitable for those with severe mental illness, other nonepileptic events, participation in another therapy, severe intellectual disability, or comorbid epilepsy.

What is being tested?

The study tests Retraining and Control Therapy (ReACT), which aims to improve the sense of control and reduce catastrophic symptom expectations in children with PNES through twelve sessions. The effectiveness will be measured using tasks like holding a hand in cool water and questionnaires before treatment, after certain sessions, and up to one year later.

What are the potential side effects?

Since ReACT is a behavioral intervention focusing on changing thoughts and behaviors rather than medication, it may not have typical drug side effects. However, participants might experience discomfort during the cold pressor test or stress from confronting their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 9 and 18 years old.

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My seizures have been diagnosed as non-epileptic by a doctor using a special video test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have epilepsy in addition to my primary condition.

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I have a severe intellectual disability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magic and turbulence task

Pain Rating Scale

Pain catastrophizing scale for children- situation specific

+3 more

Secondary study objectives

Anxiety Sensitivity Index (ASI)

COVID-19 Functional Neurological Disorders (FND) Questionnaire

Childhood Trauma Questionnaire

+19 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: ReACT for PNES- No Booster therapy sessionsExperimental Treatment1 Intervention

After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.

Group II: CPT- Pain sensitivity lotionExperimental Treatment1 Intervention

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

Group III: CPT- Pain relief lotionExperimental Treatment1 Intervention

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

Group IV: Healthy ControlActive Control1 Intervention

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.

Group V: ReACT for PNES- Booster therapy sessionsActive Control1 Intervention

After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ReACT

2016

N/A

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Nonepileptic Seizures (PNES) that align with the principles of Retraining and Control Therapy (ReACT) involve cognitive-behavioral therapy (CBT) and other psychotherapeutic approaches. These treatments work by helping patients identify and modify dysfunctional thoughts and behaviors that contribute to their seizures. By improving the patient's sense of control and reducing catastrophic symptom expectations, these therapies can decrease the frequency and severity of PNES episodes. This is crucial for PNES patients as it addresses the underlying psychological factors, leading to better management of their condition and an improved quality of life.

The reduction of seizure-like behaviors through contingency management.Treatment approach in a child with hysterical seizures superimposed on partial complex seizures.Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review.